ATAZANAVIR

Product NDC
69097-445
11-digit product format
690970445
Labeler code
69097
Product ID
69097-445_39d9f838-5059-4ac4-be71-96280e2cfe2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atazanavir
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA200626
Marketing category
ANDA
Marketing start
2018-09-14
Marketing end
0000-00-00
Substance
ATAZANAVIR SULFATE
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69097-445DDiscontinued by firm2026-10-12
excluded packagepackage69097-44569097-445-02DDiscontinued by firm2026-10-12
excluded packagepackage69097-44569097-445-03DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69097-445-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69097-445-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69097-445-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69097-445-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69097-445-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69097-445-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69097-445-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69097-445-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69097-445-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69097-445-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69097-445-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69097-445-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69097-445-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69097-445-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69097-445-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69097-445-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69097-445-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69097-445-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69097-445-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69097-445-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69097-445-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69097-445-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69097-445-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69097-445-02557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200626-001ATAZANAVIR SULFATEATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORAL2018-08-09
A200626-002ATAZANAVIR SULFATEATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORAL2018-08-09
A200626-003ATAZANAVIR SULFATEATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORAL2018-08-09
A200626-004ATAZANAVIR SULFATEATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORAL2018-08-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A200626-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORAL2018-08-0984e616aacf4f…
2026-09-14 22:38:342026-08A200626-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORAL2018-08-0984e616aacf4f…
2026-09-14 22:38:342026-08A200626-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORAL2018-08-0984e616aacf4f…
2026-09-14 22:38:342026-08A200626-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORAL2018-08-0984e616aacf4f…
2026-08-18 06:07:402026-07A200626-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORAL2018-08-09caaa826d4ba7…
2026-08-18 06:07:402026-07A200626-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORAL2018-08-09caaa826d4ba7…
2026-08-18 06:07:402026-07A200626-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORAL2018-08-09caaa826d4ba7…
2026-08-18 06:07:402026-07A200626-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORAL2018-08-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200626-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORAL2018-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200626-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORAL2018-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200626-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORAL2018-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200626-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORAL2018-08-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200626-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORAL2018-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200626-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORAL2018-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200626-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORAL2018-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200626-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORAL2018-08-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A200626-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORAL2018-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200626-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORAL2018-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200626-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORAL2018-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200626-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORAL2018-08-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200626-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORAL2018-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200626-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORAL2018-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200626-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORAL2018-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200626-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORAL2018-08-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200626-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORAL2018-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200626-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORAL2018-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200626-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORAL2018-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200626-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORAL2018-08-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200626-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORAL2018-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200626-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORAL2018-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200626-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORAL2018-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200626-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORAL2018-08-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200626-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORAL2018-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200626-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORAL2018-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200626-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORAL2018-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200626-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORAL2018-08-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200626-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORAL2018-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200626-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORAL2018-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200626-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORAL2018-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200626-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORAL2018-08-095bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-14 00:12 UTC2019-12A200626-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A200626-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A200626-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A200626-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A200626-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A200626-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A200626-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A200626-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200626-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A200626-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A200626-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A200626-004AB1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200626-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200626-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200626-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200626-004AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200626-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200626-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200626-003AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200626-004AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A200626-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A200626-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A200626-003AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A200626-004AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A200626-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A200626-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A200626-003AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A200626-004AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200626-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200626-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200626-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200626-004AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200626-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A200626-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A200626-003AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A200626-004AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200626-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A200626-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A200626-003AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A200626-004AB1e64feba35796…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-445-03EA - Each69097-4450f844fa3-2191-4e29-857e-91bedb0328cd12018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-445-026909704450230 CAPSULE, GELATIN COATED in 1 BOTTLE (69097-445-02) 2018-09-140000-00-00NoNoCurrent
69097-445-036909704450360 CAPSULE, GELATIN COATED in 1 BOTTLE (69097-445-03) 2018-09-140000-00-00NoNoCurrent